Immune Checkpoint Inhibitor Adverse Events from FAERS Database, 320,556 Reports

320,556 adverse event reports for eight immune checkpoint inhibitors, involving 123,210 patients, were analyzed using disproportionality methods. The study, authored by Caihong Qu and posted in 2026, systematically ranks safety signals across System Organ Class, Standardized MedDRA Query, and Preferred Term levels. Endocrine and hepatobiliary disorders showed the strongest signals, while cardiac and respiratory toxicities had the highest mortality risks.

Use Cases

• Ranking organ system toxicity risks based on disproportionality analysis signals.
• Comparing mortality risks of different immune-related adverse event types.
• Identifying high-signal adverse events at the Preferred Term level for clinical monitoring.

Strengths

• Analysis includes 320,556 adverse event reports from a major regulatory database.
• Employs three established disproportionality methods for signal detection.
• Stratifies results across three MedDRA hierarchy levels (SOC, SMQ, PT).

Limitations

• Description metadata is limited; actual data quality requires manual inspection after download.
• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Duplicate records and reports from nonprofessionals were removed; disproportionality analysis performed.

Freshness

Last updated 2026-05-01 05:24:36; freshness should be verified.